GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory
FDA device recall Z-0001-2007 · posted 2006-10-03 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
- Action taken
- Consignees were notified by letter on 05/31/2006
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 143 units
- Distribution
- Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
- Date initiated
- 2006-05-31
- Date posted
- 2006-10-03
- Date terminated
- 2011-07-27
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |